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A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
Phase 2 trial testing Atezolizumab in Carcinoma, Non-Small-Cell Lung in 23 participants. Completed in 10 February 2023.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 9 September 2020 |
| Primary completion | 19 January 2022 |
| Estimated completion | 10 February 2023 |
| Sites | 10 locations across China |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions \>=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 18.2 | 5.19 – 40.28 |
Duration of objective response (DOR) was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 6.36 | 2.66 – NA |
Time to response (TTR) was defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 1.577 | ± 0.490 |
Disease control rate (DCR) was defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 65.2 | 42.73 – 83.62 |
OS after enrollment was defined as the time from enrollment to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 14.06 | 8.80 – 22.14 |
Progression-free survival (PFS) was defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 2.76 | 1.35 – 4.07 |
PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 13.91 | 3.49 – 31.36 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 4.64 | 0.33 – 19.26 |
OS rate at 1 and 2 years was defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 52.17 | 30.51 – 70.01 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 30.43 | 13.54 – 49.28 |
Percentage of participants with adverse events.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 23 |
Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment. The AESIs were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. The grading is as follows: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 7 |
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 1 |
Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 17.4 | 4.95 – 38.78 |
Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).
| Group | Value | 95% CI |
|---|---|---|
| Atezolizumab Plus Bevacizumab | 65.2 | 42.73 – 83.62 |
Time frame: Baseline up to approximately 2.5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Atezolizumab Plus Bevacizu… |
|---|---|---|
| Death | General disorders | — |
| Malaise | General disorders | — |
| Left ventricular dysfunction | Cardiac disorders | — |
| Gastroenteritis | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Platelet count decreased | Investigations | — |
| Reaction | System | Atezolizumab Plus Bevacizu… |
|---|---|---|
| Proteinuria | Renal and urinary disorders | — |
| Fatigue | General disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Blood thyroid stimulating hormone increased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hypercholesterolaemia | Metabolism and nutrition disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Weight decreased | Investigations | — |
| Hypothyroidism | Endocrine disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Blood bilirubin increased | Investigations | — |
| Blood creatine phosphokinase increased | Investigations | — |
| Urinary occult blood positive | Investigations | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Thyroxine free decreased | Investigations | — |
| White blood cells urine positive | Investigations | — |
Most-reported serious reactions: Death, Malaise, Left ventricular dysfunction, Gastroenteritis, Pneumonia, Upper respiratory tract infection, Platelet count decreased.
Data from ClinicalTrials.gov NCT04426825 adverse events section.
This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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